Percutaneous method and device to treat dissections

ABSTRACT

Some embodiments of the present disclosure are directed to methods and systems for percutaneously treating dissections in a patient&#39;s vasculature, such as, without limitation, the aorta. The method can include deploying a catheter containing a collapsed anchoring element, frame, and cover through a first vessel to an entry point of the dissection. In some embodiments, the anchoring element can be secured to the second branch vessel. The frame can be expanded in the first branch vessel. The cover can be unfolded over at least a portion of the entry point. The cover then reduces blood flow into the entry point.

PRIORITY INFORMATION AND INCORPORATION BY REFERENCE

This application claims the benefit of U.S. Provisional PatentApplication No. 61/174,888, filed on May 1, 2009, the entire content ofwhich is hereby incorporated by reference and should be considered partof this specification. Additionally, U.S. patent application Ser. No.12/101,863, filed on Apr. 11, 2008 (entitled “Bifurcated GraftDeployment Systems And Methods”) is also hereby incorporated byreference in its entirety as if fully set forth herein.

BACKGROUND OF THE DISCLOSURE

The present disclosure relates to a method and device for the treatmentof aortic dissections.

An aortic dissection is a dangerous condition with high mortality rates.In an aortic dissection, a tear typically develops in the intima of theaorta that propagates along the vessel wall delaminating the inner layerof the aorta from the outer layer. Blood enters the space between thelayers creating a false lumen. Several additional tears or entry pointscan be created between the true lumen of the aorta and the false lumen.In the acute phase, dissections may close a perfusion from the aorta tovital organs. In the chronic phase, the weakened tissue can develop intoan aneurysm and ultimately rupture. Dissections involving the ascendingaorta are referred to as Type A dissections. Dissections only involvingthe descending aorta are referred to as Type B dissections.

Current treatments for dissections include medical management to lowerthe blood pressure of the patient and reduce the hemodynamic stresses onthe diseased vessel. If dissections are symptomatic, surgicalintervention is necessary. Portions of the diseased aorta are replacedby a surgical graft and the dissection flap is reattached. Morerecently, stent grafts have been used to close the primary entry pointinto the false lumen with the goal to thrombose the false lumen andmaintain patency of the true lumen.

Endovascular treatment of aortic dissections with a thoracic aorticstent graft may risk inter-operative and post-operative complications.The catheter delivery systems of thoracic stent grafts typically have aprofile of 20-24Fr, requiring a cut-down or conduit for delivery. Vesseldamage by the large delivery catheters is common. Stent grafts aredifficult to deploy accurately in the thoracic aorta due to the highblood flow through the thoracic aorta. The proximal end of the stentgraft, particularly uncovered stent sections, may cause the dissectiontear to propagate proximally into the aortic arch.

There is a clear need for an improved method to treat aorticdissections. The current application describes certain embodiments,which provide a solution to the treatment of aortic dissections whileminimizing the impact on the aorta.

SUMMARY OF SOME EMBODIMENTS

Some embodiments of the present disclosure are directed to methods fortreating a vascular dissection, comprising advancing a cathetercomprising a cover and a collapsed anchoring element connected to aframe through a first vessel to an entry point of the dissection,securing the anchoring element to a second vessel that is incommunication with the first vessel, expanding the frame in the firstvessel, and unfolding and positioning the cover over at least a portionof the entry point. In some embodiments, the cover can reduce blood flowinto the entry point.

Some embodiments are directed to methods for treating a vasculardissection, comprising advancing a catheter supporting a prosthesis toan entry point of the dissection, wherein the entry point of thedissection is located in a first vessel and the prosthesis comprises acover and a collapsible anchoring element in communication with thecover, securing the anchoring element to a second vessel that is incommunication with the first vessel, expanding the cover in the firstvessel, and positioning the cover over at least a portion of the entrypoint of the dissection. In some embodiments, the cover can beconfigured to reduce blood flow into the entry point of the dissection.

Some embodiments are directed to a device for treating vasculardissections, comprising an anchoring element, a frame supported by theanchoring element, and a cover supported by the frame. The cover can beconfigured to cover a portion of a wall of a first vessel over an entrypoint into the dissection to at least substantially reduce blood flowinto the entry point. The anchoring element can be configured to besupported by a second vessel in communication with the first vessel.Some embodiments are directed to a device for treating vasculardissections, comprising an anchoring element and a cover supported bythe anchoring element, wherein the cover is configured to cover only aportion of a wall of a first vessel over an entry point into thedissection and is configured to at least substantially reduce blood flowinto the entry point, and the anchoring element is configured to bedeployed within a second vessel in communication with the first vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentdisclosure will now be described in connection with non-exclusiveembodiments, in reference to the accompanying drawings. The illustratedembodiments, however, are merely examples and are not intended to limitthe invention. The following are brief descriptions of the drawings,which may not be drawn to scale.

FIG. 1 is a schematic illustration of a type B dissection in the aorta.

FIG. 2A illustrates an embodiment of a device to treat dissections.

FIG. 2B is a schematic illustration of the embodiment of the treatmentdevice illustrated in FIG. 2A, taken along line 2B-2B in FIG. 2A.

FIGS. 3A and 3B illustrate another embodiment of a device to treatdissections.

FIGS. 4A and 4B illustrate another embodiment of a device to treatdissections.

FIG. 5 illustrates another embodiment of a device to treat dissections.

FIGS. 6A and 6B illustrate another embodiment of a device to treatdissections.

FIGS. 7A and 7B illustrate another embodiment of a device to treatdissections.

FIGS. 8A and 8B are schematic side view representations of an embodimentof a device to treat dissections, wherein a support member is shown in acollapsed state in FIG. 8A and an expanded state in FIG. 8B.

FIG. 9A is a partial section schematic view of an embodiment of adelivery catheter that can be used to deploy some embodiments of thedevices to treat dissections disclosed herein.

FIG. 9B is a partial section schematic view of the embodiment of thedelivery catheter shown in FIG. 9A, showing an embodiment of a device totreat dissections supported therein.

FIG. 10 is a schematic illustration of patient's aorta having a type Bdissection therein, showing a guidewire being advanced through apatient's subclavian artery into the aorta.

FIG. 11 is a schematic illustration showing an embodiment of a deliverycatheter being advanced over the guidewire of FIG. 10.

FIGS. 12 and 13 are schematic illustrations showing the embodiment ofthe device to treat dissections of FIG. 9B being deployed from theembodiment of the delivery catheter of FIG. 11.

FIG. 14 is a schematic illustration showing the embodiment of the deviceto treat dissections of FIG. 9B deployed within the patient'svasculature.

FIG. 15 is a schematic illustration of patient's aorta having a type Bdissection therein, showing a guidewire being advanced through apatient's aorta into the subclavian artery.

FIG. 16 is a schematic illustration showing an embodiment of a deliverycatheter being advanced over the guidewire of FIG. 16.

FIGS. 17 and 18 are schematic illustrations showing an embodiment of adevice to treat dissections being deployed from the embodiment of thedelivery catheter of FIG. 16.

FIG. 19 is a schematic illustration showing an embodiment of the deviceto treat dissections deployed within the patient's vasculature.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

Some embodiments of the present application pertain to methods oftreating aortic dissections. Specifically, without limitation, thesemethods may be well suited for the treatment of acute Type B dissectionsinvolving the descending aorta, or for the treatment of dissections ortears anywhere in a human or animal vasculature.

Current devices used for the endovascular treatment of dissections areaortic stent grafts that require delivery systems of 20-24Fr. Thesestent grafts rely on a large diameter stent for anchoring in the aortaand have a graft that covers the complete circumference of the aorta.

By anchoring the device in a branch vessel, as in some embodiments ofthis disclosure, the need for an aortic stent is removed. By coveringonly the flap of the dissection, as in some embodiments disclosedherein, less covering material is necessary. Some embodiments of theprosthesis, as described in greater detail below, can be delivered in alow-profile catheter of less than 12Fr, or, in some embodiments, lessthan 8Fr. Furthermore, the device can be directly delivered from thebranch vessel.

Some embodiments herein relate to devices and methods for creating athrombosis in the false lumen of a dissection by closing the primaryentry point of the dissection with a patch or a cover instead of a stentgraft. In Type B dissections, the primary entry point is typicallylocated at the transition region from the aortic arch to the descendingthoracic aorta, distal to the subclavian artery. In some embodimentsdisclosed herein, a patch can be positioned over the entry point of thedissection. The patch can be, for example and without limitation,anchored in or secured to the subclavian artery. For example, in someembodiments, the radial artery can be punctured to deliver the deviceinto the subclavian artery. In situations where the entry point to thedissection is located at a different section of the aorta, other branchvessels may be utilized for anchoring the device. In some embodiments,the patch can be configured so as to not cover the entire inner surfaceof the blood vessel, such as, but not limited to, the aorta, but can,rather, cover only a portion of the wall of the blood vessel.

FIG. 1 is a schematic illustration of a type B dissection in the aorta.A tear or entry point 3 in the inner layer of the aorta 1 distal to thesubclavian artery 2 can be severe enough to allow blood to enter intothe aortic wall and peel the inner layer 4 of the aorta from the outerlayer 5. Arrow A1 in FIG. 1 represents the flow of blood into the aorticwall. The space created by the blood between the two layers is referredto as the false lumen 6. The tear 3 is referred to as the entry point tothe false lumen. The separated inner layer 4 is referred to as the flap.In some embodiments, the dissection is treated by closing the entrypoint so that the blood cannot enter and pressurize the false lumen 6.

FIGS. 2A and 2B show an embodiment of a treatment device tosubstantially or fully close the entry point of a type B dissection inthe aorta. In some embodiments, the device or prosthesis can comprise acover 11 and a support member or anchoring element 12. In someembodiments, the cover 11 or any cover of any other device or prosthesisembodiment disclosed herein can be sufficiently rigid to beself-supporting within the target vessel after being deployed. In someembodiments, however, as in the illustrated embodiment, the device canhave a collapsible frame 10 configured to support the cover 11. In someembodiments, the cover 11 or any other cover disclosed herein can beconfigured to have an integral frame or support structure such that anadditional frame is not required. Additionally, some embodiments of thecover or the frame disclosed herein, including without limitation cover11 and frame 10, can be biased or otherwise be configured to deflect ormove against or adjacent to the vessel wall at the location of the entrypoint to the dissection upon deployment from a suitable delivery device.

The device can be collapsed into a low-profile delivery catheter forpercutaneous delivery to the treatment site. Preferably, the device canbe delivered from the radial artery or the femoral artery. Thecollapsible frame 10 can be made from a shape memory material,including, without limitation, Nitinol. In some embodiments, the shapeof the frame 10 can be elliptical to conform to the aortic wall. Thecover 11 can be suspended in the frame 10.

In some embodiments, the cover 11 can be made from a biocompatible,flexible, thin material. Potential materials include, but are notlimited to, polyester, ePTFE, polyurethane, silk, animal tissue or anyother materials suitable for long-term implants. In some embodiments,the cover 11 can be made from a material that promotes or assists tissuerepair and integration of the cover 11 into the aortic wall. In someembodiments, the cover 11 can be made from matrices designed to act as ascaffold for tissue-engineered grafts. The cover 11 can compriseproteins such as, without limitation, collagen and elastin, which arenatural building blocks of the extracellular matrix in the aortic wall.

In some embodiments, the cover 11 can comprise fibrin, polysaccharides,like chitosan or glycosaminoglycans. In some embodiments, the proteinscan be cross-linked by a suitable cross-linking agent. Suitablecross-linking agents can include, without limitation, glutaraldehydes,carbodiimide, tannins, polyphenols, and photo-activated cross-linkingagents. In some embodiments, the protein layer can be harvested frommammals. Possible sources of mammalian protein layers include, withoutlimitation, pericardium, small intestine submucosa, blood vessels, andskin.

In some embodiments, the thickness of the cover 11 can range fromapproximately 0.0001 inches to approximately 0.01 inches. In someembodiments, the thickness of the cover 11 can be from approximately0.0005 inches to approximately 0.0020 inches. The cover 11 can be madefrom non-porous materials, porous materials, a mesh, or from knitted orwoven fibers. In some embodiments, the biochemical and surfaceproperties of the cover 11 can promote adhesion of the cover to theaortic wall. For example, the cover 11 can be made from a knittedpolyester or silk fabric. The cover 11 can be attached to the frame 10with sutures, adhesive, or with any other suitable fasteners ortechniques. In some embodiments, the cover 11 can be molded directlyonto the frame.

The frame 10 can move from a collapsed state during deployment to anexpanded state after deployment into the aorta. In some embodiments, theframe 10 can unfold the cover 11 during deployment. The blood flow canpush the cover against the aortic wall, thus helping to secure the cover11 at the target location. The flexible cover 11 can conform to the wallof the aorta 1 and can seal off the entry point 3. To prevent migrationof the cover 11, the frame 10 can be connected to an anchoring element12 that can be placed in a side branch of the aorta, preferably thesubclavian artery 2. The anchoring element 12 can be placed in anysuitable branch vessel of the aorta, including without limitation thecarotid or brachiocephalic artery. The anchoring element 12 or any otheranchoring element or support member can be a self-expandable stent,balloon-expandable stent, coil, hook, barb, balloon, stent graft, screw,staple, or other similar or suitable device.

FIGS. 3A and 3B illustrate another embodiment of a device to treatdissections. With reference to FIG. 3A, in some embodiments, the cover22 can have a half-circular or ovular shape. The frame 21 can comprisean arcuately-shaped wire. In some embodiments, the cover 22 can beunsupported at the distal end. In FIG. 3B, a further alternativeembodiment of the cover 32 is shown. As shown therein, some embodimentsof the cover 32 can extend proximally beyond the anchoring element 33,which may be suitable for situations in which the entry point 3 is at orproximal to the subclavian artery. The subclavian artery can be coveredby the cover 32. In some embodiments, the cover 32 can have an openingto allow blood to enter into the subclavian artery. In some embodiments,the frame 31 can have an additional central strut 34 support the cover31 or to push the cover 31 against the aortic wall.

FIGS. 4A and 4B illustrate another embodiment of a device to treatdissections. With reference to FIG. 4A, the device can have one or moresupports 41 a-e that can be connected to the anchoring element 43. Thesupports 41 a-e can be supported on one end by the proximal end of theanchoring element 43. Alternatively, the supports 51 a-e can besupported by the distal end of anchoring element 53 as shown in FIG. 4B.

FIG. 5 illustrates another embodiment of a device to treat dissections,configured to substantially or fully close the entry point of a type Bdissection in the aorta. In some embodiments, the device can be similarto that shown in FIG. 2. In some embodiments, a support element 64 canbe connected to the distal end of the frame 61. In some embodiments, thesupport element 64 can push the frame 61 and cover 62 against the flap 4of the dissection. The support element 64 can have an elliptical shapeand can be made from a similar material as the frame 61. The ellipse canbe slightly larger than the diameter of the aorta 1 so that the supportelement 64 can be in contact with the flap 4 and the opposing aorticwall 65. The support element 64 can be comprised to support a distalportion of the frame 61 so as to prevent or inhibit the distal portionof the cover 62 from detaching or moving away from the flap 4.

FIGS. 6A and 6B illustrate another embodiment of a device configured tosubstantially or fully close the entry point of a type B dissection inthe aorta. In some embodiments, the frame 71 can comprise two ellipticalelements 71 a and 71 b that can form an open cage. The cover 72 can beconfigured to conform to or be supported by one half of the frame 71.When placed in the aorta 1, some embodiments of the frame can preventthe cover 72 from detaching or moving away from the flap 4. Further,some embodiments of the frame can conform to the local cross-sectionalarea of the aorta.

FIGS. 7A and 7B illustrate another embodiment of a device tosubstantially or fully close the entry point of a type B dissection inthe aorta. In some embodiments, the device can be similar to the deviceshown in FIG. 2, except as described below. A support element 84 can besupported by the anchor element 81. The support element 84 can beadvanced through the entry point 3 into the false lumen 6 and cansupport the frame 81 from within the false lumen 6. The frame 81 and thesupport element 84 can effectively sandwich the flap 4 and can preventthe cover 82 from detaching from the flap 4. In some embodiments, theframe 81 or the support element 84 can perform a clip-like function.

FIGS. 8A and 8B are schematic side view representations of an embodimentof a device 100 to treat dissections, wherein a support member 92 isshown in a collapsed state in FIG. 8A and an expanded state in FIG. 8B.The device 100 can have any of the same features, components, or otherdetails of any other embodiments of the devices to treat dissectionsdisclosed herein. Accordingly, the support member 92 (also referred toas an anchor member herein) can be any suitable stent, including withoutlimitation a self-expandable, balloon expandable stent, or any otheranchoring element disclosed herein that can be deployed in a vessel thatis adjacent to the vessel having the dissection therein. The supportmember 92 can be collapsed during delivery and expanded once the supportmember 92 is positioned in the target vessel location. As illustratedtherein, a cover member 94 can be attached to the support member 92 andcan be configured to substantially or completely cover the entry pointto the dissection.

FIG. 9A is a partial section schematic view of a delivery catheter 100that can be used to deploy some embodiments of the devices to treatdissections disclosed herein, such as without limitation the device 90described above. In some embodiments, the delivery catheter 100 can haveany or any combination of the features, components, or other details ofthe delivery catheter embodiments disclosed in U.S. application Ser. No.12/101,863, filed on Apr. 11, 2008 and entitled “Bifurcated GraftDeployment Systems And Methods,” which application is herebyincorporated by reference as if fully set forth herein.

With reference to FIG. 9A, the delivery catheter 100 can have an innercore 102 that can extend from a proximal end of the delivery catheter100 through a lumen in an outer sheath 104. The inner core 102 can beaxially and rotationally movable within the outer sheath 104. A tubemember 106 can extend from a distal end portion of the inner core 102and can support an atraumatic distal tip 108. A guidewire lumen 110 canbe formed through the axial centerline of the distal tip 108, the tubemember 106, and the inner core 102.

FIG. 9B is a partial section schematic view of the delivery cathetershown in FIG. 9A, showing the embodiment of the device 90 to treatdissections supported therein. In some embodiments, the outer sheath 104can be used to restrain the anchoring member 92 and the cover 94, bothof which can be supported within the delivery catheter 100 in acollapsed configuration. Additionally, in some embodiments, although notrequired, a frame member can be attached to the anchoring member 92 andcan be used to support the cover 106. The device 100 can be supported bythe tube member 106 and radially restrained by the outer sheath 104 and,as will be described. As will be described, the radial restraint can beremoved by retracting the outer sheath 104 relative to the inner core102, thereby exposing the device 100.

With the foregoing description, several arrangements of methods todeploy a device to treat a dissection will be described. With referenceto FIG. 10, which is a schematic illustration of patient's aorta havinga type B dissection therein, a guidewire 120 can be advanced through apatient's subclavian artery 2 into the aorta 7. In some embodiments, theguidewire can be advanced into the subclavian artery 2 through apatient's radial artery. FIG. 11 is a schematic illustration showing thedelivery catheter 100 being advanced over the guidewire 120. In thisarrangement, the delivery catheter 100 can be advanced through apatient's radial artery into the subclavian and aortic arteries.

FIGS. 12 and 13 are schematic illustrations showing the device 90 totreat dissections of FIG. 9B being deployed from the delivery catheter100. As illustrated in FIG. 12, the cover 94 can be deployed from thedelivery catheter 100 be axially retracting the outer sheath 104relative to the tube member 106, thereby exposing the cover member 94.The delivery catheter 100 and prosthesis 90 can be properly positionedusing one or more radiopaque markers supported on the delivery catheter100 and/or prosthesis 90. Because the delivery catheter 100 was advancedthrough the subclavian artery 2 into the aorta 7, further axialretraction of the outer sheath 104 relative to the inner core 102 andtube member 106 can cause the anchor member 92 to be deployed from thedelivery catheter 100 into the subclavian artier 2. Thereafter, thedeployment catheter 100 can be axially retracted through the subclavianand radial artery and be removed from the body, as shown in FIG. 14. Theguidewire 120 can thereafter be removed, leaving only the device 90 fortreating dissections.

In some embodiments, the cover 94 of the device 90 can be deployed in apatient's aorta by first advancing a guidewire 120 through a patient'sfemoral artery into the aorta and subclavian arteries, as illustrated inFIG. 15. Thereafter, the deployment catheter 100 described above can beadvanced over the guidewire 120, as illustrated in FIG. 16. Once thedelivery catheter 100 has reached the target location, e.g., within thesubclavian artery 2, the anchoring member 92 can be deployed within thesubclavian artery 2 by axially retracting the outer sheath 104 relativeto the tube member 106 and device 90, as illustrated in FIG. 17. Furtherretraction of the outer sheath 104 can cause the remaining components ofthe device 90 to be deployed within the patient's vasculature. Forexample, with reference to FIG. 18, further retraction of the outersheath 104 can cause the cover member 94 to be deployed and tosubstantially or completely cover the entry point 3 to the dissection.

Thereafter, the deployment catheter 100 can be axially retracted throughthe aorta and femoral artery and be removed from the body, as shown inFIG. 19. The guidewire 120 can thereafter be removed, leaving only thedevice 90 for treating dissections.

FIGS. 2-19 illustrate some embodiments of devices and methods of thepresent disclosure. Other embodiments that support the proposed methodof entry point closure are also within the scope of the presentdisclosure. For example, in some embodiments, a collapsable device canbe placed over the entry point and anchored to an aortic branch vesselthat can be delivered with a low-profile catheter-based delivery system.

Although the inventions have been disclosed in the context of preferredembodiments and examples, it will be understood by those skilled in theart that the present disclosure extends beyond the specificallydisclosed embodiments to other alternative embodiments and/or uses ofthe invention and obvious modifications and equivalents thereof. Inaddition, while a number of variations of the invention have been shownand described in detail, other modifications, which are within the scopeof this invention, will be readily apparent to those of skill in the artbased upon this disclosure. It can be also contemplated that variouscombinations or subcombinations of the specific features and aspects ofthe embodiments can be made and still fall within the scope of theinvention. Accordingly, it should be understood that various featuresand aspects of the disclosed embodiments can be combined with orsubstituted for one another in order to form varying modes of thedisclosed invention. Thus, it can be intended that the scope of thepresent disclosure herein disclosed should not be limited by theparticular disclosed embodiments described above.

1. A method for treating a vascular dissection, comprising: advancing acatheter supporting a prosthesis to an entry point of the dissection,wherein the entry point of the dissection is located in a first vesseland the prosthesis comprises a cover and a collapsible anchoring elementin communication with the cover; securing the anchoring element to asecond vessel that is in communication with the first vessel; expandingthe cover in the first vessel; and positioning the cover over at least aportion of the entry point of the dissection; wherein the cover isconfigured to reduce blood flow into the entry point of the dissection.2. The method of claim 1, wherein cover is supported by a collapsibleframe and wherein the frame is connected to the anchoring element. 3.The method of claim 2, wherein the frame has an elliptical shape.
 4. Themethod of claim 1, wherein the first or second vessel is the aorta. 5.The method of claim 1, wherein the cover is configured to cover only aportion of an inner perimeter of the first vessel.
 6. The method ofclaim 1, wherein the second vessel is proximal to the entry point of thedissection.
 7. The method of claim 1, wherein the first vessel is thesubclavian artery.
 8. The method of claim 1, wherein the first vessel isthe left carotid artery.
 9. The method of claim 1, wherein the secondvessel is a brachiocephalic artery.
 10. The method of claim 1, whereinthe cover comprises a protein matrix.
 11. The method of claim 10,wherein the protein matrix comprises at least one of collagen, elastin,and mammalian tissue.
 12. The method of claim 10, wherein the mammaliantissue comprises tissue harvested from a pericardium or a smallintestine submucosa.
 13. The method of claim 1, further comprisingadvancing a support element of the prosthesis through the entry point ofthe dissection.
 14. The method of claim 1, wherein the anchoring elementis a stent.
 15. A device for treating a vascular dissection, comprising:an anchoring element; and a cover supported by the anchoring element;wherein: the cover is configured to cover only a portion of a wall of afirst vessel over an entry point into the dissection and is configuredto at least substantially reduce blood flow into the entry point; andthe anchoring element is configured to be deployed within a secondvessel in communication with the first vessel.
 16. The device of claim15, wherein the anchoring element and cover are collapsible into a firstcollapsed state for positioning within a catheter and are expandable toa second expanded state.
 17. The device of claim 15, further comprisinga frame configured to support the cover, the frame being attached to theanchoring element.
 18. The device of claim 17, wherein the anchoringelement, frame, and cover are collapsible into a first collapsed statefor positioning within a catheter and expandable to a second expandedstate.
 19. The device of claim 17, wherein the frame is configured tounfold the cover during deployment of the frame.
 20. The device of claim17, wherein the cover is attached to the frame using sutures oradhesive.
 21. The device of claim 17, wherein the frame comprises twointerconnected elliptical components.
 22. The device of claim 17,wherein the frame comprises a memory material such as Nitinol.
 23. Thedevice of claim 15, wherein the cover comprises at least one of aprotein matrix, polyester, ePTFE, polyurethane, silk, and animal tissue.24. The device of claim 23, wherein the protein matrix comprises atleast one of mammalian tissue, collagen, elastin, fibrin,polysaccharides such as chitosan or glycosaminoglycans, and across-linking agent.
 25. The device of claim 24, wherein thecross-linking agents comprise at least one of glutaraldehydes,carbodiimide, tannins, polyphenols, and photo-activated cross-linkingagents.
 26. The device of claim 24, wherein the mammalian tissuecomprises tissue harvested from pericardium, small intestine submucosa,blood vessels, or skin.
 27. The device of claim 15, wherein theanchoring element is a stent.
 28. The device of claim 15, wherein theanchoring element comprises at least one of a coil, hook, barb, balloon,stent graft, screw, or staple.
 29. The device of claim 15, wherein thecover is configured to contact at least a portion of the first vessel.30. The device of claim 15, further comprising a plurality of supportsattached to the anchoring element and configured to support the cover.31. The device of claim 15, wherein a thickness of the cover is betweenapproximately 0.0001 inches and approximately 0.01 inches.